Catalog Number

-

Brand Name

Equate

Version/Model Number

583961970 (68255WM)

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OHY

Product Code Name

Pill Crusher/Cutter

Public Device Record Key

966bf0fb-650b-4394-9377-f41e8fd078ce

Public Version Date

September 24, 2020

Public Version Number

1

DI Record Publish Date

September 16, 2020

Package DI Number

20025715000989

Quantity per Package

3

Contains DI Package

00681131360449

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

inner